Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode

Beirut Arab University20 enrolled

Overview

The goal of this clinical trial is to compare clinical and digital color parameter results of gingival depigmentation using blue laser in both contact and non- contact modes in patients with physiological gingival hyperpigmentation. The main questions it aims to answer are: * Which intervention will provide less pain? * Which intervention will provide better gingival depigmentation? Participants will undergo: * Mechanical plaque removal * Infiltration using Articaine 4% * Blue diode laser (445 nm) application to the gingiva either from a 2-mm distance in one group or directly to the gingiva in the other group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Physiological Gingival Hyperpigmentation

Interventions

Infiltration anesthesia using 4% Articaine was given. Blue light laser (445 nm, 1.5 W) was applied to patients with physiologic hyperpigmentation using 300 µm fiber-optic tip at a distance of 2mm from the target area in constant movement until gingival blanching was observed.

Gingival depigmentation using blue laser in contact modePROCEDURE

Infiltration anesthesia using 4% Articaine was given. Blue light laser (445 nm, 1 W) was applied to patients with physiologic hyperpigmentation using 300 µm fiber-optic tip directly touching the target area until ablation was observed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with physiological gingival hyperpigmentation. * Patients free from systemic diseases or with controlled systemic diseases * Age range between 18 and 40 * Non smokers Exclusion Criteria: * Patients with poor oral hygiene * Immunosuppressed patients * Patients with uncontrolled systemic diseases * Patients having malignancies at the treatment site * Patients with photosensitive conditions or on photosensitizing medications * Pregnant women

Outcomes

Primary Outcomes

Postoperative pain

Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants will record their perceived pain following the laser depigmentation procedure. Unit of measure: Score

Time frame: immediately after the procedure, 24 hours post operatively, and 7 days post operatively.

Degree of gingival pigmentation

Degree of gingival pigmentation was assessed using the Dummett Oral Pigmentation Index (DOPI).

Time frame: 1 and 3 months after completion of the procedure.

Extent and distribution of gingival pigmentation

Extent and distribution of gingival pigmentation were measured using Hedin Melanin Index (HMI)

Time frame: 1 and 3 months after completion of the procedure.

Secondary Outcomes

Changes in gingival color

Changes in gingival color will be assessed by calculating ΔE from standardized digital photographs using CIELAB L\*, a\*, and b\* color coordinates. ΔE represents the overall color difference between baseline and postoperative measurements. Unit of measure: None/ dimensionless

Time frame: 1 and 3 months after completion of the procedure